Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
Sponsor
Orion Corporation, Orion Pharma (Industry)
Overall Status
Completed
CT.gov ID
NCT01429064
Collaborator
(none)
76
17
1
53
4.5
0.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate safety and tolerability of ODM-201 in patients with castrate resistant prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
76 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001
Study Start Date
:
Jun 1, 2011
Actual Primary Completion Date
:
Nov 1, 2015
Actual Study Completion Date
:
Nov 1, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ODM-201
|
Drug: ODM-201
ODM-201 administered orally daily
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Adverse Events [From first dose of study treatment up to 4 weeks after last dose of study treatment]
Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Written informed consent
-
Successful completion of study protocol 3104001
-
Response or stable disease in study 3104001 at week 12
Exclusion Criteria:
-
New serious concurrent medical condition
-
Not able to swallow the study drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Urology Center of Colorado | Wheat Ridge | Colorado | United States | 80211 |
| 2 | Eastern CT Hematology and Oncology Associates | Norwich | Connecticut | United States | 06360 |
| 3 | Cleveland Clinic | Cleveland | Ohio | United States | 44195 |
| 4 | Carolina Urologic Research Center | Myrtle Beach | South Carolina | United States | 29572 |
| 5 | Klinika onkologie a radioterapie LFUK a FN | Hradec Králové | Czech Republic | ||
| 6 | East-Tallinn Central Hospital | Tallinn | Estonia | ||
| 7 | Helsinki University Central Hospital | Helsinki | Finland | ||
| 8 | Kuopio University Hospital | Kuopio | Finland | ||
| 9 | Oulu University Hospital | Oulu | Finland | ||
| 10 | Tampere University Hospital | Tampere | Finland | ||
| 11 | Turku University Hospital | Turku | Finland | ||
| 12 | Saint Louis Hospital | Paris | France | ||
| 13 | Institut Gustave Roussy | Villejuif | France | ||
| 14 | Queen Elizabeth Hospital | Birmingham | United Kingdom | ||
| 15 | Velindre Cancer Centre | Cardiff | United Kingdom | ||
| 16 | Christie Hospital | Manchester | United Kingdom | ||
| 17 | Churchill Hospital | Oxford | United Kingdom |
Sponsors and Collaborators
- Orion Corporation, Orion Pharma
Investigators
- Principal Investigator: Karim Fizazi, Gustave Roussy, Cancer Campus, Grand Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01429064
Other Study ID Numbers:
- 3104002
First Posted:
Sep 5, 2011
Last Update Posted:
Feb 20, 2017
Last Verified:
Jan 1, 2017
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled at 17 hospitals in Europe and in the USA |
|---|---|
| Pre-assignment Detail | Patients with response or stable disease at week 12 in ARADES 3104001 study as judged by the investigator, were allowed to continue in the ARADES-EXT 3104002 extension study. |
| Arm/Group Title | Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) |
|---|---|---|---|---|
| Arm/Group Description | 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. |
| Period Title: Overall Study | ||||
| STARTED | 19 | 22 | 19 | 16 |
| COMPLETED | 19 | 22 | 19 | 16 |
| NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) | Total |
|---|---|---|---|---|---|
| Arm/Group Description | 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Total of all reporting groups |
| Overall Participants | 19 | 22 | 19 | 16 | 76 |
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
68.8
(6.1)
|
66.5
(6.6)
|
68.9
(8.3)
|
74.6
(6.3)
|
69.4
(7.3)
|
| Gender (Count of Participants) | |||||
| Female |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Male |
19
100%
|
22
100%
|
19
100%
|
16
100%
|
76
100%
|
Outcome Measures
| Title | Number of Participants With Adverse Events |
|---|---|
| Description | Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months. |
| Time Frame | From first dose of study treatment up to 4 weeks after last dose of study treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) |
|---|---|---|---|---|
| Arm/Group Description | 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. |
| Measure Participants | 19 | 22 | 19 | 16 |
| Number [participants] |
19
100%
|
22
100%
|
19
100%
|
16
100%
|
Adverse Events
| Time Frame | From first dose of study treatment up to 4 weeks after last dose of study treatment. Median duration on study treatment was 11,0 months. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) | ||||
| Arm/Group Description | 200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor. | ||||
All Cause Mortality |
||||||||
| Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 5/19 (26.3%) | 7/22 (31.8%) | 3/19 (15.8%) | 4/16 (25%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Cardiac disorders | ||||||||
| Atrial fibrillation | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Cardiac failure | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Constipation | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Diarrhoea | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Ileus paralytic | 1/19 (5.3%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Nausea | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Vomiting | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| General disorders | ||||||||
| Chills | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Fatigue | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Pain | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Pyrexia | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Infections and infestations | ||||||||
| Diverticulitis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Enterobacter infection | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Gastroenteritis | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Infection | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Liver abscess | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Lung infection | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Pneumonia | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Pyelonephritis | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Stenotrophomonas infection | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Urinary tract infection | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Urosepsis | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Cervical vertebral fracture | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Contusion | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Facial bones fracture | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Fall | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Laceration | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Investigations | ||||||||
| Enterobacter test positive | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Hyperkalaemia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Hyponatraemia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Back pain | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 2/16 (12.5%) | ||||
| Muscular weakness | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Rectal adenocarcinoma | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Nervous system disorders | ||||||||
| Cerebral ischaemia | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Syncope | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Psychiatric disorders | ||||||||
| Confusional state | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Insomnia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Acute kidney injury | 0/19 (0%) | 2/22 (9.1%) | 0/19 (0%) | 0/16 (0%) | ||||
| Calculus urinary | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Hydronephrosis | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Urethral stenosis | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Urinary incontinence | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Urinary retention | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Dyspnoea | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Sleep apnoea syndrome | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Angioedema | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Vascular disorders | ||||||||
| Deep vein thrombosis | 1/19 (5.3%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Lymphoedema | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Orthostatic hypotension | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Patients From Arades 3104001 Dose Escalation | Patients From Arades 3104001 Dose Expansion (200mg/Day) | Patients From Arades 3104001 Dose Expansion (400mg/Day) | Patients From Arades 3104001 Dose Expansion (1400mg/Day) | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 19/19 (100%) | 22/22 (100%) | 19/19 (100%) | 16/16 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 0/19 (0%) | 1/22 (4.5%) | 2/19 (10.5%) | 1/16 (6.3%) | ||||
| Lymphadenopathy | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Cardiac disorders | ||||||||
| Cardiac failure | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Coronary artery disease | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Mitral valve incompetence | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Palpitations | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Supraventricular extrasystoles | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Supraventricular tachycardia | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Tachycardia | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Ventricular extrasystoles | 1/19 (5.3%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Ear and labyrinth disorders | ||||||||
| Ear pain | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Motion sickness | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Eye disorders | ||||||||
| Eye pain | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Eye pruritus | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Eyelid oedema | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Ocular hyperaemia | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Periorbital oedema | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Visual acuity reduced | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal distension | 1/19 (5.3%) | 1/22 (4.5%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Abdominal pain | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Abdominal pain upper | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Abnormal faeces | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Anal fissure | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Aphthous stomatitis | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Cheilitis | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Constipation | 3/19 (15.8%) | 3/22 (13.6%) | 3/19 (15.8%) | 2/16 (12.5%) | ||||
| Diarrhoea | 9/19 (47.4%) | 0/22 (0%) | 2/19 (10.5%) | 1/16 (6.3%) | ||||
| Dry mouth | 1/19 (5.3%) | 1/22 (4.5%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Dyspepsia | 0/19 (0%) | 0/22 (0%) | 2/19 (10.5%) | 3/16 (18.8%) | ||||
| Flatulence | 2/19 (10.5%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Gastritis | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Gingival pain | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Haemorrhoidal haemorrhage | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Nausea | 5/19 (26.3%) | 2/22 (9.1%) | 3/19 (15.8%) | 3/16 (18.8%) | ||||
| Oesophagitis | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Rectal haemorrhage | 1/19 (5.3%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Stomatitis | 2/19 (10.5%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Tongue discolouration | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Vomiting | 3/19 (15.8%) | 0/22 (0%) | 1/19 (5.3%) | 2/16 (12.5%) | ||||
| General disorders | ||||||||
| Asthenia | 5/19 (26.3%) | 1/22 (4.5%) | 2/19 (10.5%) | 0/16 (0%) | ||||
| Chest pain | 1/19 (5.3%) | 0/22 (0%) | 2/19 (10.5%) | 0/16 (0%) | ||||
| Face oedema | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Fatigue | 5/19 (26.3%) | 3/22 (13.6%) | 5/19 (26.3%) | 8/16 (50%) | ||||
| Influenza like illness | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Localised oedema | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Malaise | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Oedema peripheral | 3/19 (15.8%) | 2/22 (9.1%) | 1/19 (5.3%) | 5/16 (31.3%) | ||||
| Pain | 4/19 (21.1%) | 7/22 (31.8%) | 1/19 (5.3%) | 3/16 (18.8%) | ||||
| Peripheral swelling | 1/19 (5.3%) | 2/22 (9.1%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Pyrexia | 0/19 (0%) | 2/22 (9.1%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Immune system disorders | ||||||||
| Hypersensitivity | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Cellulitis | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Eye infection | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Gastroenteritis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Herpes zoster | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Infection | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Influenza | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Lower respiratory tract infection | 1/19 (5.3%) | 1/22 (4.5%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Nasopharyngitis | 4/19 (21.1%) | 2/22 (9.1%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Onychomycosis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Oral herpes | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Pyelonephritis acute | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Rhinitis | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Sinusitis | 1/19 (5.3%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Tinea cruris | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Tooth abscess | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Tooth infection | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Upper respiratory tract infection | 0/19 (0%) | 2/22 (9.1%) | 0/19 (0%) | 0/16 (0%) | ||||
| Urinary tract infection | 3/19 (15.8%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Viral infection | 1/19 (5.3%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Contusion | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 3/16 (18.8%) | ||||
| Fall | 0/19 (0%) | 2/22 (9.1%) | 1/19 (5.3%) | 2/16 (12.5%) | ||||
| Foot fracture | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Infusion related reaction | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Laceration | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 2/16 (12.5%) | ||||
| Ligament sprain | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Muscle strain | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Rib fracture | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Sunburn | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Investigations | ||||||||
| Blood alkaline phosphatase increased | 1/19 (5.3%) | 0/22 (0%) | 2/19 (10.5%) | 1/16 (6.3%) | ||||
| Blood creatinine increased | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Blood lactate dehydrogenase increased | 1/19 (5.3%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Blood pressure increased | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Blood urine present | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Cardiac murmur | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Electrocardiogram PR prolongation | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Electrocardiogram QT prolonged | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Heart rate increased | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Liver palpable | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Urine output increased | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Weight decreased | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Weight increased | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Cachexia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Decreased appetite | 1/19 (5.3%) | 3/22 (13.6%) | 5/19 (26.3%) | 2/16 (12.5%) | ||||
| Hyperuricaemia | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Hypoalbuminaemia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Hypocalcaemia | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Hypoglycaemia | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 6/19 (31.6%) | 7/22 (31.8%) | 3/19 (15.8%) | 3/16 (18.8%) | ||||
| Arthritis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Back pain | 7/19 (36.8%) | 4/22 (18.2%) | 5/19 (26.3%) | 6/16 (37.5%) | ||||
| Bone pain | 2/19 (10.5%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Bursitis | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Dupuytren's contracture | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Exposed bone in jaw | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Flank pain | 0/19 (0%) | 3/22 (13.6%) | 0/19 (0%) | 0/16 (0%) | ||||
| Groin pain | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Joint lock | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Joint stiffness | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Joint swelling | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 2/16 (12.5%) | ||||
| Muscle spasms | 2/19 (10.5%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Muscular weakness | 1/19 (5.3%) | 2/22 (9.1%) | 0/19 (0%) | 2/16 (12.5%) | ||||
| Musculoskeletal chest pain | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Musculoskeletal pain | 1/19 (5.3%) | 2/22 (9.1%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Myalgia | 2/19 (10.5%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Neck pain | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 2/16 (12.5%) | ||||
| Osteoarthritis | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Pain in extremity | 1/19 (5.3%) | 2/22 (9.1%) | 2/19 (10.5%) | 0/16 (0%) | ||||
| Pain in jaw | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Pathological fracture | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Spinal pain | 2/19 (10.5%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Bowen's disease | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Cancer pain | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Meningioma | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Metastases to liver | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Nervous system disorders | ||||||||
| Ageusia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Areflexia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Dizziness | 2/19 (10.5%) | 1/22 (4.5%) | 3/19 (15.8%) | 0/16 (0%) | ||||
| Headache | 4/19 (21.1%) | 2/22 (9.1%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Hypoaesthesia | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Hyporeflexia | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Lethargy | 0/19 (0%) | 2/22 (9.1%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Monoparesis | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Neuropathy peripheral | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Paraesthesia | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Paraplegia | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Petit mal epilepsy | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Presyncope | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Sciatica | 3/19 (15.8%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Somnolence | 2/19 (10.5%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Tremor | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Psychiatric disorders | ||||||||
| Affective disorder | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Alcohol abuse | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Confusional state | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Depression | 1/19 (5.3%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Insomnia | 2/19 (10.5%) | 1/22 (4.5%) | 3/19 (15.8%) | 1/16 (6.3%) | ||||
| Sleep disorder | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Renal and urinary disorders | ||||||||
| Bladder dilatation | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Dysuria | 2/19 (10.5%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Haematuria | 1/19 (5.3%) | 3/22 (13.6%) | 1/19 (5.3%) | 2/16 (12.5%) | ||||
| Haemorrhage urinary tract | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Hydronephrosis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Lower urinary tract symptoms | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Micturition frequency decreased | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Micturition urgency | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Nocturia | 0/19 (0%) | 2/22 (9.1%) | 0/19 (0%) | 0/16 (0%) | ||||
| Pollakiuria | 1/19 (5.3%) | 0/22 (0%) | 2/19 (10.5%) | 0/16 (0%) | ||||
| Urinary incontinence | 1/19 (5.3%) | 0/22 (0%) | 1/19 (5.3%) | 2/16 (12.5%) | ||||
| Urinary retention | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Urinary tract inflammation | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Breast tenderness | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Erectile dysfunction | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Gynaecomastia | 3/19 (15.8%) | 1/22 (4.5%) | 2/19 (10.5%) | 1/16 (6.3%) | ||||
| Pelvic pain | 1/19 (5.3%) | 2/22 (9.1%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Penile oedema | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Cough | 3/19 (15.8%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Dyspnoea | 3/19 (15.8%) | 2/22 (9.1%) | 0/19 (0%) | 0/16 (0%) | ||||
| Dyspnoea exertional | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Epistaxis | 1/19 (5.3%) | 1/22 (4.5%) | 1/19 (5.3%) | 1/16 (6.3%) | ||||
| Oropharyngeal pain | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Pharyngeal erythema | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Pleural effusion | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Pulmonary embolism | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Rales | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Rhinorrhoea | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Wheezing | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Actinic keratosis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Dry skin | 2/19 (10.5%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Erythema | 2/19 (10.5%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Hyperhidrosis | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Nail discolouration | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Night sweats | 0/19 (0%) | 1/22 (4.5%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Onychoclasis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Pruritus | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Rash | 2/19 (10.5%) | 1/22 (4.5%) | 0/19 (0%) | 2/16 (12.5%) | ||||
| Skin atrophy | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Skin lesion | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Urticaria | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Vascular disorders | ||||||||
| Aortic arteriosclerosis | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Circulatory collapse | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Deep vein thrombosis | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Flushing | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Hot flush | 1/19 (5.3%) | 1/22 (4.5%) | 3/19 (15.8%) | 2/16 (12.5%) | ||||
| Hypertension | 2/19 (10.5%) | 2/22 (9.1%) | 2/19 (10.5%) | 3/16 (18.8%) | ||||
| Intermittent claudication | 0/19 (0%) | 1/22 (4.5%) | 0/19 (0%) | 0/16 (0%) | ||||
| Lymphoedema | 2/19 (10.5%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Pelvic venous thrombosis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
| Poor peripheral circulation | 0/19 (0%) | 0/22 (0%) | 0/19 (0%) | 1/16 (6.3%) | ||||
| Superficial vein prominence | 1/19 (5.3%) | 0/22 (0%) | 0/19 (0%) | 0/16 (0%) | ||||
| Lymphostasis | 0/19 (0%) | 0/22 (0%) | 1/19 (5.3%) | 0/16 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Head of Oncology |
|---|---|
| Organization | Orion Pharma, Development, R&D |
| Phone | +358 10 4261 |
| mika.mustonen@orionpharma.com |
Responsible Party:
Orion Corporation, Orion Pharma
ClinicalTrials.gov Identifier:
NCT01429064
Other Study ID Numbers:
- 3104002
First Posted:
Sep 5, 2011
Last Update Posted:
Feb 20, 2017
Last Verified:
Jan 1, 2017